Non-invasive Nerve Stimulation and Cognitive Training to Improve Cognitive Performance in Healthy Older Adults

• Sponsor: University of Florida (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04276805
• Collaborator: University of Arizona (Other), McKnight Brain Research Foundation (Other)
• Enrollment: 40
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 25
• Patients Per Site: 20
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

We need better tools to both enhance brain health and improve cognitive performance in healthy brain aging so that it can be delayed, reduced, or even reversed. The present proposal is designed to evaluate the pairing of cognitive training with a non-invasive neurostimulation technology that has shown promise in both increasing neuroplasticity and in enhancing cognitive performance, transcutaneous vagal nerve stimulation (tVNS).

Condition or Disease	Intervention/Treatment	Phase
Aging	Device: Transcutaneous vagal nerve stimulation (tVNS); Behavioral: cognitive training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Non-invasive Nerve Stimulation and Cognitive Training to Improve Cognitive Performance in Healthy Older Adults
• Actual Study Start Date: Nov 17, 2020
• Anticipated Primary Completion Date: Dec 17, 2022
• Anticipated Study Completion Date: Dec 17, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: tVNS group Participants will undergo cognitive training with tVNS	Device: Transcutaneous vagal nerve stimulation (tVNS); a non-invasive and safe technique that transiently enhances brain GABA and noradrenaline levels.; Behavioral: cognitive training; A program of regular mental activities purported to maintain or improve one's cognitive abilities.
Sham Comparator: Sham group Participants will undergo cognitive training with earlobe sham	Behavioral: cognitive training; A program of regular mental activities purported to maintain or improve one's cognitive abilities.

Outcome Measures

Primary Outcome Measures

1. Change in working memory and processing speed contributors [Baseline to 2 weeks]

   The Posit Science BrainHQ

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy individuals willing to commit to study requirements

Exclusion Criteria:

• Neurological disorders to include traumatic brain injury.

• Evidence of dementia .

• Major psychiatric illness

• Unstable and chronic medical conditions.

• MRI contraindications (e.g., pregnancy, claustrophobia, metal implants that are contraindicated for MRI).

• Physical impairment precluding motor response or lying still or walking

• Hearing or vision deficits that will not allow for completion of assessments

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona	Tucson	Arizona	United States	85721
2	University of Florida	Gainesville	Florida	United States	32610

Sponsors and Collaborators

• University of Florida
• University of Arizona
• McKnight Brain Research Foundation

Investigators

• Principal Investigator: John Williamson, PhD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT04276805
• Other Study ID Numbers: IRB201902991
• First Posted: Feb 19, 2020
• Last Update Posted: Jun 16, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

No Results Posted as of Jun 16, 2022